Dry Eye Disease

November 6, 2017

RegeneRx Biopharmaceuticals and ReGenTree reported results of a phase III trial of RGN-259 compared to placebo for dry eye syndrome. The ocular discomfort symptom showed a statistically significant reduction in the RGN-259-treated group at day 15 as compared to placebo (p=0.0149) in the change from baseline. For sign, RGN-259 also improved the dry eye patient’s ability to withstand an exacerbated condition in a patient subgroup with both compromised corneal fluorescein staining and Schirmer’s test at baseline. In this population, RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). RGN-259 confirmed its global effects on dry eye syndrome and fast onset in multiple sign and symptom efficacies with no safety issues in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2 was not successful in duplicating the results of ARISE-1 where the study population was limited and less diversified. ReGenTree plans to proceed with a development plan for the next step through a meeting with the FDA based on the results of ARISE-2 trial.

January 16, 2017

Sun Pharma issued results of a phase III trial of Seciera (cyclosporine A, 0.09% ophthalmic solution) for the treatment of dry eye disease. In this 12 week, multicenter, randomized, double-masked, vehicle-controlled confirmatory study, 744 dry eye patients were treated either with Seciera, or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.0001). The demonstration of efficacy by Seciera at 12 weeks is earlier than other drugs approved for dry eye in the same class. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle with some showing an even earlier onset of action. Adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category. The company will discuss results with the FDA.

May 30, 2016

RegeneRx Biopharmaceuticals issued results of a phase II/III trial of RGN-259 for the treatment of dry eye. The 317-patient trial demonstrated statistically significant improvements in both signs and symptoms of dry eye with 0.05% and 0.1% RGN-259 compared to placebo in a dose dependent manner during a 28-day dosing period. While the primary outcome measures were not met, several key related pre-specified endpoints and subgroups of patients with more severe dry eye showed statistically significant treatment effects. On the final day of dosing (day 28), patients receiving 0.1% RGN-259 had a statistically significant reduction in ocular discomfort during Controlled Adverse Environment (CAE) Model exposure when compared to placebo (Intent-to-Treat Population (ITT), p=0.043). Importantly, this result was also observed in the previous phase II trial in patients treated with 0.1% RGN-259 (ITT, p=0.024), thereby demonstrating a symptom endpoint in two independent trials. A statistically significant ocular discomfort improvement after CAE exposure on day 28 was also observed in the 0.05% and 0.1% RGN-259 treatment arms when compared to placebo (ITT, p=0.0366 and p=0.0072, respectively) indicating a dose dependent response. Efficacy in an environmental setting was also demonstrated in more symptomatic patients at baseline, with statistically significant improvements in ocular discomfort observed at day 28 prior to CAE in patients receiving 0.05% and 0.1% RGN-259 compared to placebo (p=0.022 and p=0.006, respectively). The company plans to conduct a confirmatory phase III study to start by the fourth quarter of 2016.

November 16, 2015

Shire has released results of a phase III study of lifitegrast for dry eye disease. OPUS-3 compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in patients with dry eye, a recent history of artificial tear use within 30 days of study entry and an eye dryness score (EDS)=40. Lifitegrast met the single primary endpoint for patient-reported symptoms of eye dryness (mean change in Eye Dryness Score from baseline to week 12) (treatment difference of 7.16 [95% CI], 3.04, 11.28; p=0.0007). In OPUS-3, lifitegrast met the secondary endpoints of symptom improvement at days 14 and 42 (treatment difference (95% CI) 7.85(4.33, 11.37) and 9.32 (5.44, 13.20) respectively, (p<0.0001)). OPUS-3 topline results replicated the co-primary symptom endpoint of OPUS-2, a phase III efficacy and safety study (p<0.0001). OPUS-2 did not meet the co-primary endpoint for the sign of inferior corneal staining score, (p=0.6186). Shire plans to use those data as part of the resubmission of the NDA for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016.

August 3, 2015

Allegro Ophthalmics reported results of a phase II trial of Luminate (ALG-1001) in patients with vitreomacular traction (VMT) or vitreomacular adhesion (VMA). The prospective, randomized, double-masked, placebo-controlled trial evaluated Luminate in 106 study subjects. Sixty-five percent of eyes treated with the 3.2mg dose of Luminate achieved release of VMT or VMA by day 90 (end-of-study), compared to 9.7% of those in the placebo control group (p=0.0129). The study, which included three Luminate groups (2mg, 2.5mg or 3.2mg) and a balanced salt solution (BSS) placebo group, also found that Luminate was well tolerated, with no drug toxicity or intraocular inflammation noted with repeated intravitreal injections. Currently in phase II clinical trials for multiple indications, including diabetic macular edema and non-proliferative diabetic retinopathy, Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S.

June 8, 2015

RegeneRx Biopharmaceuticals issued results of a phase II study of RGN-259 for treatment of dry eye patients using Ora's controlled adverse environment (CAE) model. The 72-patient, placebo-controlled study demonstrated statistically significant improvements in the RGN-259-treated group compared to placebo (p=0.0075, p=0.0210 and p=0.0379, respectively). RGN-259 also reduced exacerbation of ocular discomfort after CAE challenge (p=0.0224). The drug candidate was well-tolerated and there were no observed adverse side effects. The co-primary outcome measures, inferior corneal staining and patient ocular discomfort 24 hours after CAE challenge did not show statistically significant differences. A larger, multicenter, phase IIb/III U.S. clinical trial is targeted for later in 2015.

June 1, 2015

Eleven Biotherapeutics released results of a phase III study of EBI-005 for moderate-to-severe dry eye disease. The pivotal, multicenter, double-masked, randomized, controlled study of EBI-005 5mg/mL evaluated 669 patients. There was no statistically significant difference between the EBI-005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI-005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints. While the change from baseline on the co-primary endpoints was greater in the vehicle group than the EBI-005 group, the differences between the two groups were not statistically significant or clinically meaningful. EBI-005 was generally well-tolerated with fewer than 5% of patients reporting eye irritation and no treatment-related serious adverse events. Approximately 13% of patients in the study reported some use of artificial tears, with no difference in artificial tear use between the EBI- 005 treated and vehicle control groups. Eleven continues to prepare to advance EBI-005 into late-stage clinical development for allergic conjunctivitis, with plans to initiate a pivotal phase III study in patients with moderate-to-severe allergic conjunctivitis in the second half of 2015.

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